OMB.report

Federal forms, ICRs, and supporting documents

Information Collection Request

Guidance for Industry on How to Use E-Mail to Submit a Notice of Final Disposition of Invest. Animals Not Intended for Immediate Slaughter

ICR 201004-0910-011 · OMB 0910-0453 · Historical Active

Forms and Documents
DocumentTypeStatusAvailability
Form FDA 3487 Guidance for Industry on How to Use E-Mail to Submit a Notice of Final Disposition of Animals Not Intended for Immediate Slaughter Form and Instruction Modified Available
Guidance - 0910-0453.pdf Supplementary Document Uploaded 2007-02-12 Available
SS-0910-0453.doc Supporting Statement A Uploaded 2010-04-27 Available
IC Document Collections
IC IDCollectionTypeStatusForm
6142 Guidance for Industry on How to Use E-Mail to Submit a Notice of Final Disposition of Animals Not Intended for Immediate Slaughter Form and Instruction Modified
ICR Details
0910-0453 201004-0910-011
Historical Active 200702-0910-007
HHS/FDA
Guidance for Industry on How to Use E-Mail to Submit a Notice of Final Disposition of Invest. Animals Not Intended for Immediate Slaughter
Extension without change of a currently approved collection   No
Regular
Approved without change 12/01/2010
Retrieve Notice of Action (NOA) 04/30/2010
  Inventory as of this Action Requested Previously Approved
12/31/2013 36 Months From Approved 08/31/2010
16 0 36
1 0 3
0 0 0
CVM monitors the final disposition of food animals treated with investigational new animal drugs in situations where the treated animals do not enter the human food chain immediately at the completion of the investigational study. As part of this process provides sponsors must provide notice of disposition.
US Code: 21 USC 360(b)(3) Name of Law: null
  
None
Not associated with rulemaking
  75 FR 6037 02/05/2010
75 FR 22598 04/29/2010
No
  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 16 36 0 0 -20 0
Annual Time Burden (Hours) 1 3 0 0 -2 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
$60
No
No
No
No
No
Uncollected
Denver Presley 3018271462
  No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
04/30/2010